Day-to-Day Life

At SUANFARMA´s CDMO Quality Department, our mornings kickstart with a vibrant and dynamic meeting involving various departments such as Production, QC, QA, HSE, Warehouse, Finance, R&D, Maintenance, and Engineering. This collaborative session serves as a platform for discussing daily occurrences, ensuring alignment with the manufacturing plan, reviewing product expeditions, and addressing any emerging issues. It is an opportunity to redefine priorities and collectively strategize the best approach. Throughout the day, the Quality team communicates swiftly via meetings and email exchanges, making thoughtful decisions that directly impact operational activities.

Key Objectives and Challenges

One of the most critical aspects of achieving our objectives lies in establishing quality parameters that are measurable, consistent with our inherent quality policy, and relevant to product and service conformity. However, amidst the hectic routine, this task is not always easy. Hence, the availability of qualified and committed collaborators, along with the necessary resources, becomes paramount in ensuring our success.

Evolving Customer Relationships

Our customer relationships are built on professionalism and transparency. We place great emphasis on fostering good rapport with our customers, being collaborative, and readily available to address any challenges that arise. The Quality team aligns seamlessly with our company’s goal of not only being a product-oriented plant but also a service-oriented one, catering to our customers’ evolving needs.

Inspiring Success Stories

One of our remarkable success stories stems from our team’s adaptability and flexibility. We successfully transitioned from solely producing the same APIs to embracing several projects involving new products in the Synthesis and Fermentation areas. The Quality Control team faced numerous challenges, including improving and validating analytical methods provided by customers. Simultaneously, Quality Assurance adjusted its mindset, maintaining a proactive GMP approach to ensure excellence across the entire plant, irrespective of the project’s initial complexities.

Satisfying Aspects of Daily Work

The true joy of our daily work lies in the power of teamwork. It is incredibly satisfying to be part of a team that thrives in finding answers to challenges encountered in our day-to-day operations. Our company nurtures an environment that strikes a balance between leadership, respect, and cooperation, where hierarchy formalities take a back seat. We encourage open communication, allowing every team member to freely express their thoughts and contribute valuable suggestions for improvement.

Main Difficulties and Challenges

Keeping a sense of quality ingrained in our mindset presents a daily challenge. Quality is not just a department’s responsibility but a collective effort that each one of us must embody. We strive to maintain this focus amidst various operational complexities and ensure that excellence permeates every aspect of our work.

Why Count on SUANFARMA CDMO from a Quality Perspective? Our Value Proposition

We pride ourselves on implementing an all-around Good Manufacturing Practices (GMP) culture. Our commitment to quality is valued and acknowledged by our clients, evident through successful external audits and inspections. We consistently deliver on our promise of maintaining a robust quality system that instills trust and confidence in our customers. Our unwavering dedication to quality sets us apart, making SUANFARMA CDMO the preferred choice for those seeking excellence in their partnerships.

In conclusion, the Quality Department of SUANFARMA CDMO operates with a relentless pursuit of quality, adapting to challenges, and building strong relationships with our customers.

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The Quality Assurance Team is responsible for ensuring that all processes involved in the production and control of the active pharmaceutical ingredients (APIs) meet the pre-defined acceptance criteria set by the Health Authorities. Their mission is to prevent, monitor, and manage any potential negative impact on product quality. In summary, they ensure that established standards are met to provide safe and effective medications to patients.

On the other hand, the Quality Control Team is dedicated to the thorough analysis of the compliance of all incoming materials used in production, including intermediate products, as well as conducting continuous testing of manufactured products. Their goal is to ensure that all products meet the established regulatory requirements. This involves evaluating the quality and conformity of the products through rigorous testing, ensuring each one meets the applicable quality standards and norms.

In the field of regulations, each active ingredient must meet specific requirements:

• Firstly, compliance with the Pharmacopeia monographs is necessary. Pharmacopeia is a regulatory pharmaceutical code that varies by country. These monographs describe the quality requirements and characteristics that medications must possess, categorizing them into different classes.
• Additionally, active ingredients must be manufactured according to Good Manufacturing Practices (GMP), which are a set of guidelines that establish minimum requirements to ensure the standard quality of the product and, consequently, patient safety. This involves following established procedures within the company, as well as international guidelines and information dossiers submitted to National Health Authorities. The objective is to ensure that products do not have any “anomalies,” such as impurities, even in minimal quantities, that could have side effects on patients.
• Once both requirements are met, an application for site approval as a manufacturer of a specific active ingredient must be submitted to the regulatory authorities. This application must be accompanied by a file called a Drug Master File (DMF), which details all activities conducted at the site regarding each API, such as the manufacturing process, analytical controls, and stability studies. After a rigorous evaluation, the health authorities will authorize the production of the active ingredient.

Product safety is a constant priority, and regular internal and external inspections are carried out to ensure compliance with quality standards and regulatory requirements.

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By utilizing its core brands of Gonmisol, Monteloeder and Suanfarma USA, SUANNUTRA will be structured to pursue market-leading growth in Branded and Innovative ingredients whilst enhancing its market presence in Functional and Essential ingredients through its long-established commitment to quality and innovation and its position as a trusted leader in the nutraceutical market.

With 1,400 active customers in 50 countries and a network in Europe, USA, and Asia, SUANNUTRA is a truly global player and reliable partner driving innovation in novel products and customer service.   Product awards and recognition have been received for innovative branded ingredients by industry recognized international organizations.

Anthony Weston, CEO of SUANNUTRA states “I’m very happy to join the excellent team of SUANNUTRA. Together, we will enhance our presence in the global nutraceuticals market through our science-backed product line, new innovations and exciting partnerships and collaborations.”   To achieve these ambitious goals, SUANNUTRA is committed to strengthening its team with the best talent, further consolidating its position as an industry leader.

” We are excited to welcome Anthony Weston as the new CEO of SUANNUTRA, effective June 5^th,” says Francisco Fernández who will continue to lead SUANFARMA in its ambitious growth plans and will continue to support SUANNUTRA and Anthony as a key advisor. “SUANFARMA has full confidence in Anthony’s inspiring leadership, strategic vision, and ability to overcome challenges, to lead SUANNUTRA to new levels of success.”

Anthony’s extensive background in global business management and leadership most recently at Frutarom and IFF, coupled with his clear focus on delivering sustained profitable growth and enhanced value through organic business development, product innovation, manufacturing excellence, and successful acquisitions and integrations, make him an ideal fit for the role.

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Let us introduce you to our key goals:

Environmental compliance: We ensure that we comply with all applicable environmental regulations in each country where we operate. We recognise the importance of respecting laws and regulations to ensure the preservation of our natural resources.

Resource efficiency: We seek to minimise and optimise our resource consumption in all our activities. Through smart measures and sustainable practices, we strive to maximise efficiency in the use of resources such as water, energy and materials.

Reducing our carbon footprint: We take the challenge of climate change seriously and are committed to reducing our carbon footprint. We implement concrete actions to reduce our greenhouse gas emissions and thus contribute to climate change mitigation.

Energy savings: We are constantly looking for ways to reduce our energy consumption across our operations. Through the adoption of energy-saving measures and the implementation of low-energy equipment, we work to minimise our environmental impact and promote energy efficiency.

Use of sustainable resources and materials: We strive to minimise the use of non-renewable resources and opt for low-impact, sustainably sourced products and materials in all our facilities. We actively seek more environmentally friendly alternatives and promote the circular economy in our resource management.

Efficient waste management: We are committed to efficiently managing and recycling the waste generated in our activities. We follow the circular economy approach to minimise waste and make the best use of available resources.

Responsible use of water: We recognise the importance of water as a valuable resource and strive to use it efficiently. We reduce our water consumption and take measures to minimise the environmental impacts associated with wastewater discharge.

Sustainable transport: We actively promote low-impact transport measures among our employees in their day-to-day work. We encourage the use of public transport, shared mobility and other sustainable alternatives to reduce the environmental footprint of commuting.

These are just some of the pillars of our Sustainability Policy. We are committed to continuously working to improve our practices and to be leaders in environmental responsibility.

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One of the main uses of Lymecycline is in the treatment of moderate to severe acne. Its high activity against Propionibacterium acnes makes it a powerful tool in fighting acne outbreaks. However, Lymecycline is also useful in the treatment of Influenza type B, Gonorrhea, syphilis, Rickettsiosis, Pneumonia, Chlamydia, and Leptospirosis, which is a bacterial infection transmitted by the urine of infected animals.

Lymecycline is rapidly and completely absorbed in the digestive tract, mainly in the small intestine, and reaches its maximum concentration within 3 to 6 hours. It can be consumed as tablets and capsules, making it convenient for patients to take.

One of the biggest advantages of Lymecycline is its efficacy. Its bacteriostatic action is effective over a wide range of bacteria, and it has a good safety profile, making it generally well tolerated by patients. In addition, Lymecycline is cost-effective in several European countries, making it a popular choice for healthcare providers.

When it comes to safety, Lymecycline is a preferable option to tetracycline for the treatment of moderate to severe acne. Its high level of absorption allows it to be used at lower doses than other tetracyclines, making it less likely to cause adverse side effects.

Manufacturing

Manufacturing site and documentation are also important factors to consider when it comes to antibiotics. Lymecycline is manufactured in one of our European facilities called CIPAN, which has over 50 years of API fermentation and organic synthesis expertise. The plant has been successfully audited by European and American customers and has received EU-GMP and FDA certificates. In addition, Lymecycline has a competitive price, large scale API organic semi-synthesis units, and installed fermentation capacity in excess of 850,000 liters.

Documentation for Lymecycline is also readily available, with COA, CEP, and US DMF all accessible. Stability data for Lymecycline is also promising, with 18 months of stability data available.

In summary, Lymecycline is a powerful antibiotic that is highly effective in fighting bacterial infections. Its bacteriostatic action and good safety profile make it a popular choice for healthcare providers, and its convenient dosage forms and manufacturing site and documentation make it a reliable choice for patients.

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We would like to express our deepest gratitude to our team, customers, partners and suppliers, who have played a key role in achieving this recognition.

“We are very proud of this award. It is a recognition of the hard work we have done over the years and I would especially like to thank the whole team, Monteloeder and SUANFARMA, because this is a clear example of teamwork,” says Ignacio Cartagena CEO of Monteloeder.

With this award, Metabolaid has already won awards in all geographical areas.

Our nutraceuticals division is committed to developing natural and effective solutions that care for both people and the planet. Our ingredients are carefully crafted to provide optimal benefits for a healthier and happier life.

Metabolaid® A natural product for multifunctional cardiovascular support

Metabolaid® is a novel, patented formulation of standardised herbal extracts: hibiscus and lemon verbena. These two extracts have been formulated to act synergistically, increasing the effects of each extract by more than 6 times. Metabolaid® has been scientifically proven to help control body weight, blood pressure and help reduce appetite. An additional study demonstrates the prebiotic effect of Metabolaid®.

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Expertise in Potentially Hazardous Reactions

Our R&D laboratory is staffed with a team of highly skilled process chemists and analysts. They possess specific expertise in handling potentially hazardous reactions, such as hydrogenations, carbonylations, nitrations, and reactions in superacidic media. Our experts are trained to work with reactions spanning temperatures ranging from -80°C to +160°C, ensuring comprehensive coverage across various reaction conditions.

State-of-the-Art Laboratory Facilities

Equipped with cutting-edge technology, our R&D laboratory offers a wide range of resources for chemical synthesis. We have jacketed reactors (1L and 2L) with fluidodynamic features that mimic industrial equipment. Additionally, we provide glass and stainless steel pressure reactors/hydrogenators (ranging from 0.3L to 2L) with heating capabilities and maximum pressures of up to 200 bar. Our laboratory also boasts a lyophilizer and a dedicated analytical unit featuring LC-Mass (single quadrupole), UHPLC, and numerous HPLC instruments.

Versatile Kilolaboratory

Our GMP-compliant kilolaboratory is a versatile space that accommodates various types of chemistries. It features glass, halar-coated, and stainless steel jacketed reactors with volumetric capacity ranging from 17L to 113L. These reactors are connected to external thermocryostatic units, enabling temperature control between -20°C and +110°C. Additionally, our kilolab houses a complete distillation unit with multiple collecting reservoirs and glass condensers, a 35L jacketed Nutsche Filter, and a pressure reactor capable of withstanding pressures up to 100 bar. This reactor can be utilized with gases like H2, CO, and others. To supplement these facilities, we provide separation columns, drying ovens, basket filters, and other ancillary equipment, making our kilolab an all-encompassing resource.

Advanced Industrial Plant

Our industrial plant comprises of two complementary and versatile units. The first unit, equipped with automated remote control of reactor parameters, represents our latest technological advancement. The second unit is fully operated manually and includes multiple reactors ranging from 700L to 3600L, along with systems for contained filtration and drying. These units provide us with the flexibility to cater to a wide range of chemical synthesis requirements efficiently.

Conclusion: At SUANFARMA CDMO, our chemical synthesis capabilities are at the forefront of innovation and efficiency. With our integrated technological platform, state-of-the-art laboratory facilities, and versatile industrial plant units, we are equipped to handle any chemical synthesis process, from pilot to industrial scale. Trust us to deliver exceptional results in the field of chemical synthesis.

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One of our team’s main objectives is to optimize intermediate reprocessing processes to reduce the number of rejected batches to be destroyed, which translates into reduced waste and greater production efficiency.

Another of our focuses is the development of processes for the reuse of catalysts, which allows us to reduce the consumption of this material and minimize waste generation.

In addition, our team is working on the optimization of experimental conditions to avoid losses and degradations during the process, which means obtaining more product from the same raw materials and, therefore, reducing the use of resources.

We have also conducted a process change study to avoid the use of large amounts of solvents in extractions and industrial chromatography, as well as to increase yields. Our team is committed to reducing our environmental impact and is constantly looking for new ways to do so.

Among the measures we are implementing to achieve a sustainable system is the use of environmentally friendly solvents and the development of processes with as high a concentration as possible to reduce the use of organic solvents. We are also limiting solvent vapors and organic reagents to avoid environmental pollution, and we are using as few toxic reagents as possible.

In addition, we are exploring flow chemistry to reduce solvents, reagents, and time. This approach is directly related to energy reduction and is therefore an attractive option for improving the efficiency of our processes.

In summary, our team is committed to the continuous improvement of our industrial processes and to the reduction of environmental impact.

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In partnership with e-watts, a firm dedicated to sustainable electrochemical technology solutions and the promotion of circular economies, SUANFARMA Italia is actively involved in setting up its new electrodialysis plant. The primary aim is to utilize electrodialysis reactors and reverse osmosis technology to treat wastewater produced by the MBR plant, in a manner that adheres to water discharge regulations in an environmentally-friendly manner without the use of chemical substances.

An electrooxidation reactor comprises a sequence of electrodes constructed from a metal alloy suitable for the purpose. Upon applying an electrical current, the electrodes generate a potential difference which dissociates certain water molecules into highly reactive species, facilitating oxidation of other co-existing molecules. Subsequently, the water is subjected to reverse osmosis treatment, resulting in the production of permeate, which is released into the final discharge, and retentate, which moves to the uppermost level of the purification plant.

The testing phase is slated to begin in April, with the goal of having the entire system operational by July 2023.

We are delighted to introduce this solution as a further enhancement to the sustainability of our production system’s wastewater treatment. This facility ensures the release of high-quality water, thereby reducing environmental impacts and promoting sustainable development.

This project represents a critical milestone in our journey towards sustainable practices and social responsibility.

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OUR CUSTOMER RELATIONSHIP

We have earned their trust by being completely transparent in every aspect of our interactions. Our commitment to transparency has resulted in a deep sense of loyalty from our customers. Moreover, they appreciate our technical staff’s unique blend of youth and experience, which provides a strong foundation for our organization’s future success. We must continue to prioritize the development of our technical staff and nurture their growth to ensure that we maintain this vital asset for years to come.

OUR VALUE PROPOSITION

Cipan is a dependable partner in various aspects such as developing new proprietary products, and in assisting with Contract Manufacturing (CM) projects. By providing honest and open communication, we establish and strengthen the trust with our customers. That is why we take pride in stating that we do not simply sell products, but rather, we sell trust. By prioritizing the needs and concerns of our customers, we strive to build long-lasting partnerships based on mutual respect, integrity, and reliability.

These accomplishments signify the company’s dedication to excellence and innovation, as well as its commitment to delivering high-quality products to its customers.

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